This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.
The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.
Age 60 years or older.
Symptomatic severe native calcific aortic valve stenosis.
Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
Considered at high surgical risk for surgical aortic valve replacement.
Contraindication to transcatheter aortic valve replacement or the investigational procedure.
Active infection or endocarditis.
Life expectancy less than one year due to non-cardiac comorbidities.
Participation in another investigational study that could interfere with the objectives of this study.
Single group
Investigational Transcatheter Aortic Valve Replacement System
DeviceInvestigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis.
Percentage of Participants With Technical Success
Technical success of the investigational transcatheter aortic valve replacement procedure as assessed according to the Clinical Investigation Plan and predefined study criteria.
Percentage of Participants With Device Success
Device success following implantation of the investigational transcatheter aortic valve replacement system as assessed according to the Clinical Investigation Plan using predefined performance criteria.
Percentage of Participants Free From Early Safety Events
Early safety of the investigational transcatheter aortic valve replacement system based on predefined clinical safety criteria specified in the Clinical Investigation Plan.
All-cause Mortality rate
Assessment of all-cause mortality following implantation of the investigational transcatheter aortic valve replacement system
Cardiovascular Mortality Rate
Assessment of cardiovascular mortality during follow-up.
Percentage of Participants Experiencing Stroke
Assessment of stroke events occurring during the follow-up period
Rate of Valve- or Procedure-Related Rehospitalization
Assessment of valve- or procedure-related rehospitalization during follow-up
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